Erector Spinae Plane Block for Rib Fracture Analgesia in the Emergency Department

NCT04892563 | Unknown

• 1 other identifier: HS-21-00066
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rib fractures, while in isolation are self-limited and benign, can be exquisitely painful. Poorly controlled rib fracture pain can compromise respiratory function leading to increased morbidity and mortality, especially in the elderly. Currently, opioid medications are the mainstay of analgesia but are associated with significant adverse effects, such as respiratory depression and delirium. In an effort to improve acute pain in the ED and concomitantly reduce opioid use, ultrasound-guided regional anesthesia has been implemented more frequently The erector spinae plane block (ESPB) is a relatively new ultrasound-guided procedure for thoracic analgesia. Previously, the serratus anterior plane (SAP) block has been used for this indication. However, typical anatomical distribution limits the effectiveness of the SAP block to anterior rib fractures, while the majority of traumatic rib fractures are posterior, thus require a more central blockade such as the proposed ESPB. The ESPB can be done as a single injection into the superficial structures of the back under ultrasound guidance and as such, is a both a relatively safe and technically easy procedure to perform, especially in comparison to the more traditional alternatives of epidurals, paravertebral and intercostal injections. There have been no prospective studies evaluating the efficacy and safety of the ESPB in the emergency department setting for acute rib fractures. The investigators hypothesize that the ESPB will provide improved acute pain scores in the emergency department compared to parental analgesia alone. Secondarily, investigators hypothesize that this will translate to less inpatient opioid requirements and improved incentive spirometry values.

Conditions

Rib Fracture Multiple

Outcome Measures

Primary Outcomes (1)

• To determine the effectiveness of the ESPB for pain management of acute rib fractures in the emergency department using a 10 point isual analog scale

  Change in pain level from fractures as measured using a visual analog scale

  0, 1, 2 and 24 hours assessment

Study Arms (2)

ESPB Block

EXPERIMENTAL

Patients with rib fracture randomized to block group

Procedure: Erector Spinae Plane Block

Standard Care

ACTIVE COMPARATOR

Patients with rib fracture receiving IV analgesia/standard care

Drug: IV Analgesia

Interventions

Erector Spinae Plane Block PROCEDURE

Nerve block with local anesthetic in the erector spinae plane

Also known as: Nerve Block, Erector Spinae Block

ESPB Block

IV Analgesia DRUG

IV analgesia, typically Morphine/Opioid medications

Also known as: Morphine, Opioid

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=18
• At least 1 acute rib fracture. Acute defined as within 7 days of presentation.
• Numerical pain score on presentation at least 5 out of 10. This will identify patients that justify the invasive procedure.
• Admitted to hospital for at least 24 hours of observation.
• Be able to consent and participate in study by assuming necessary positioning for intervention

You may not qualify if:

• Hypotension/shock (shock index \>1.0, SBP \< 90)
• Distracting injury not amenable to ESPB as determined by the enrolling physician. (i.e extremity fracture, burn, laceration, contusion, joint dislocation, etc.)
• Examples of patients not able to consent/participate are intubated patients or patients in spinal precautions (i.e c-collar)
• Known hypersensitivity to local anesthetic
• Evidence of infection at the proposed site of injection

Sponsors & Collaborators

• University of Southern California: lead

MeSH Terms

Interventions

Nerve Block; Analgesia; Morphine; Analgesics, Opioid

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Tom Mailhot, MD

  LAC+USC Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Sajed

CONTACT

858 361 4685; sajed@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor (Clinican Educator), Emergency Medicine

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 19, 2021
• Study Start: July 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: August 31, 2022
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share